Taking POSNA's OrthoKids to the People

August 2, 2021 updated by: Louisiana State University Health Sciences Center in New Orleans

Taking POSNA's OrthoKids to the People: Overcoming Knowledge Disparities in Pediatric Orthopaedic Trauma

The objective of this project is to determine the efficacy of a tablet-based educational intervention at improving orthopaedic health literacy amongst families of pediatric patients treated for fractures in an outpatient setting.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This project aims to reduce knowledge disparity amongst caregivers of patients presenting for pediatric fracture care. At our institution, many patients presenting with fractures do not have easy access to either technology or the internet, preventing caregivers from benefiting from educational tools such as POSNA's OrthoKids®. We are planning to increase access and improve health literacy through a simple intervention of providing tablet-based access to POSNA's Orthokids while families are waiting for their physician. Families will be randomized to either standard waiting room experience vs. tablet-based educational intervention to limit selection bias. A brief pre-visit questionnaire will be completed by all caregivers to assess fracture and cast care knowledge as well as the highest educational degree obtained by the caregiver.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria (RCT and observational arms):

  • Children with forearm fractures who presented to the CHNOLA ED. "Children" are defined as persons under the age of 18 years for this study. "Forearm fracture" is defined as a radial and or ulnar shaft fracture for this study.
  • Documented radiographs must show an injury in which the fracture line is wholly located within the diaphysis of the radius or ulna.

Exclusion Criteria (RCT and observational arms):

  • Fractures that require internal or external fixation
  • Fractures associated with multi-system trauma
  • Caregivers that do not speak English or Spanish as their first language

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
Patients randomized to the intervention group of the RCT will be given tablet-based education. The first clinic follow-up visit will consist of screening for consent, providing a QR code for Orthokids, and conducting the pre-intervention questionnaire. The pre-intervention questionnaire has two sections with questions pertaining to demographics and orthopedic knowledge. The second clinic follow-up visit will be provided with the tablet for repeat education, with Orthokids and the post-intervention questionnaire will be distributed. The post-intervention questionnaire has two sections with questions pertaining to orthopedic knowledge and satisfaction with care.
Behavioral: Tablet-based educational intervention
POSNA's Orthokids website and the article on pediatric forearm fracture will be provided on a tablet. The article provided has two separate tabs, labeled "Condition" and "FAQs", that caregivers will be able to read through. Those who speak Spanish will have the Spanish translated version of Orthokids.
No Intervention: Control Group

Patients randomized to the control group of the RCT will receive the standard clinic experience. This group will not be exposed to any education enrichment about their child's fracture except for the physician's explanation within the exam room.

The first clinic follow-up visit will consist of screening for consent and conducting the pre-intervention questionnaire. The pre-intervention questionnaire has two sections with questions pertaining to demographics and orthopedic knowledge. The second clinic follow-up visit will consist of conducting the post-intervention questionnaire. The post-intervention questionnaire has two sections with questions pertaining to orthopedic knowledge and satisfaction with care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Knowledge questionnaire scores
Time Frame: up to the second clinic followup visit (Average 6 weeks)
up to the second clinic followup visit (Average 6 weeks)

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in caregiver satisfaction scores
Time Frame: up to the second clinic followup visit (Average 6 weeks)
up to the second clinic followup visit (Average 6 weeks)
Feedback about the OrthoKids website
Time Frame: up to the second clinic followup visit (Average 6 weeks)
up to the second clinic followup visit (Average 6 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Louisiana State University Health Sciences Center in New Orleans

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2021

Primary Completion (Anticipated)

June 1, 2022

Study Completion (Anticipated)

June 1, 2022

Study Registration Dates

First Submitted

July 27, 2021

First Submitted That Met QC Criteria

August 2, 2021

First Posted (Actual)

August 9, 2021

Study Record Updates

Last Update Posted (Actual)

August 9, 2021

Last Update Submitted That Met QC Criteria

August 2, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • POSNA's OrthoKids

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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